<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2016112321670N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-31</date_registration>
      <primary_sponsor>Abadan 17 Shahrivar hospital</primary_sponsor>
      <public_title>The study of the effect of acupressure on Hugo point on delivery pain of multiparous women</public_title>
      <acronym></acronym>
      <scientific_title>The study of the Effect of acupressure on Hugo point on delivery pain of multiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18933</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The relationship of acupressure on Hugo point and delivery pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For this group, Hugo point will be pressured by researcher for 4 cycles. Each pressure course will take 20 minutes in which, first the Hugo point will be pressured lightly and the pressure will be increased gradually in such a way that the pressure reaches its maximum within 30 seconds. This maximum pressure will be kept for one minute and then will be reduced so that the pressure will be removed from Hugo point within 30 seconds. This pressure will be repeated for 20 minutes (10 times). Then, the delivery pain again will be assessed and recorded 100 minutes after the termination of the each pressure course, the pain duration also will be asked and recorded in that time and a new pressure course will be started. The pressure courses will be continued up to 8 hours after delivery. Intervention 2: Control group: In this group, an irrelevant point other than Hugo point will be pressured by researcher for 4 cycles. Each pressure course will take 20 minutes in which, first the Hugo point will be pressured lightly and the pressure will be increased gradually in such a way that the pressure reaches its maximum within 30 seconds. This maximum pressure will be kept for one minute and then will be reduced so that the pressure will be removed from under pressure point within 30 seconds. This pressure will be repeated for 20 minutes (10 times). Then, the delivery pain again will be assessed and recorded 100 minutes after the termination of the each pressure course, the pain duration also will be asked and recorded in that time and a new pressure course will be started. The pressure courses will be continued up to 8 hours after delivery.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahla Afravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 Sharivar hospital, Shatit, Abadan, Khoozestan, Iran</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0631891331</zip>
        <telephone>+98 61 5335 4546</telephone>
        <email>af.shahla@yahoo.com</email>
        <affiliation>Abadan 17 Shahrivar hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahla Afravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 Shahrivar hospital, Shatit, Abadan, Khoozestan, Iran</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0631891331</zip>
        <telephone>+98 61 5335 4546</telephone>
        <email>af.shahla@yahoo.com</email>
        <affiliation>Abadan 17 Shahrivar hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Vaginal delivery; second to fourth pregnancy; gestational age between 37 to 42 weeks; complaint of moderate to severe delivery pain based on the standard visual pain scale assessment; infant birth weight between 2500 to 4000 gram; body mass index between 18.5 to 29    &#13;
Exclusion criteria: Hard and prolonged delivery; addiction; history of cesarean section and intra-abdominal surgery; history of postpartum hemorrhage</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>047.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>False labour at or after 37 completed weeks of gestation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For this group, Hugo point will be pressured by researcher for 4 cycles. Each pressure course will take 20 minutes in which, first the Hugo point will be pressured lightly and the pressure will be increased gradually in such a way that the pressure reaches its maximum within 30 seconds. This maximum pressure will be kept for one minute and then will be reduced so that the pressure will be removed from Hugo point within 30 seconds. This pressure will be repeated for 20 minutes (10 times). Then, the delivery pain again will be assessed and recorded 100 minutes after the termination of the each pressure course, the pain duration also will be asked and recorded in that time and a new pressure course will be started. The pressure courses will be continued up to 8 hours after delivery.</i_keyword>
      <i_keyword>Control group: In this group, an irrelevant point other than Hugo point will be pressured by researcher for 4 cycles. Each pressure course will take 20 minutes in which, first the Hugo point will be pressured lightly and the pressure will be increased gradually in such a way that the pressure reaches its maximum within 30 seconds. This maximum pressure will be kept for one minute and then will be reduced so that the pressure will be removed from under pressure point within 30 seconds. This pressure will be repeated for 20 minutes (10 times). Then, the delivery pain again will be assessed and recorded 100 minutes after the termination of the each pressure course, the pain duration also will be asked and recorded in that time and a new pressure course will be started. The pressure courses will be continued up to 8 hours after delivery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome measure of this study is severity of delivery pain. Timepoint: The severity of delivery pain will be assessed before and after each pressure course. Method of measurement: Severity of delivery pain will be assessed using standard visual pain scale assessment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Secondary outcome measure of this study is the duration of delivery pain. Timepoint: Duration of delivery pain will be assessed before and after of each pressure course. Method of measurement: Duration of delivery pain will be asked from participants and recorded.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Abadan 17 Shahrivar hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-22</approval_date>
        <contact_name>Ahvaz Jondi Shapoor University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jondi Shapoor University of Medical Sciences, University town, Ahvaz, Iran Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
